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Medtronic fixator pins - stainless steel

Official notice

19 Dec 2024

Last checked

19 Dec 2024

Medium riskHealth Canada

An official Health Canada notice concerns Medtronic fixator pins - stainless steel. Medtronic is recalling specific lots of the sterile percutaneous pin due to the potential that the pin may be unable to fit into the patient reference frame or percutaneous pin adapter when attempting to attach the components that are used in image guided surgeries. If this issue occurs, the user will be unable to connect the frame or adapter onto the percutaneous pin. This could result in surgical delay, additional surgical intervention for removal and replacement of percutaneous pin, modification of the surgical approach using an alternative device (spinous process clamp) or abandonment of the use of navigation or the procedure. Recall start date: December 4, 2024 Published 2024-12-19.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76720

Official notice

2024-12-19

The hazard

Medtronic is recalling specific lots of the sterile percutaneous pin due to the potential that the pin may be unable to fit into the patient reference frame or percutaneous pin adapter when attempting to attach the components that are used in image guided surgeries. If this issue occurs, the user will be unable to connect the frame or adapter onto the percutaneous pin. This could result in surgical delay, additional surgical intervention for removal and replacement of percutaneous pin, modification of the surgical approach using an alternative device (spinous process clamp) or abandonment of the use of navigation or the procedure. Recall start date: December 4, 2024

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76720

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Affected products

Product 1

Affected products - Fixator Pins - Stainless Steel, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 9733235 9733236

Risk / hazard

Medtronic is recalling specific lots of the sterile percutaneous pin due to the potential that the pin may be unable to fit into the patient reference frame or percutaneous pin adapter when attempting to attach the components that are used in image guided surgeries. If this issue occurs, the user will be unable to connect the frame or adapter onto the percutaneous pin. This could result in surgical delay, additional surgical intervention for removal and replacement of percutaneous pin, modification of the surgical approach using an alternative device (spinous process clamp) or abandonment of the use of navigation or the procedure. Recall start date: December 4, 2024

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic Navigation, Fixator Pins - Stainless Steel.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76720

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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